Functional uterine manipulator

ABSTRACT

A uterine manipulator operable to detach the uterus and cervix from the vagina. The uterine manipulator includes a shaft with a first end and a second end, a handle coupled to the first end, and a tip assembly coupled to the second end and adapted for insertion into the uterus. The uterine manipulator also includes a cutting assembly coupled around the shaft and adapted to receive the cervix when the tip assembly is inserted into the uterus. The cutting assembly includes a cup portion and a cutter wire. The cup portion is configured to be positioned at a juncture between the cervix and the vagina and includes with two grooves around its circumference. The cutter wire is configured to be positioned between the two grooves when in a stored position, and then pulled from between the two grooves through tissue at the juncture to cut the tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.14/375,200, which is the National Stage of International Application No.PCT/US2012/065584, filed Nov. 16, 2012, which claims the benefit of U.S.Provisional Application No. 61/592,125, filed Jan. 30, 2012, thedisclosures of which are hereby incorporated by reference in theirentirety for all purposes.

BACKGROUND OF THE INVENTION

The present invention relates generally to uterine manipulators andmethods of using a uterine manipulator for detaching the uterus andcervix from the vagina.

Uterine manipulators are conventionally used as aids in laparoscopichysterectomies to mobilize and position the uterus, to provide bettervisualization of the vagina and the cervix for facilitating theirseparation, and to remove the uterus after colpotomy is performed. Basicuterine manipulators include a handle, a shaft, an inflatable balloon,and a cervical stop. The handle is located at one side of the shaft andthe inflatable balloon is located near the tip of the other side of theshaft. The inflatable balloon is maneuvered into the uterus in andeflated condition and then inflated (e.g., via saline or water injectedthrough the shaft) to help stabilize the uterine manipulator during theprocedure and also to help remove the uterus after is has been separatedfrom the vagina. Once the uterine manipulator is positioned, thecervical stop can be adjusted to abut the cervix.

More complex uterine manipulators include a handle, a shaft, aninflatable balloon, a cervical cup, and an occluder. The handle, theshaft, and the inflatable balloon can have similar functions asdescribed above. The cervical cup can be fitted around the cervix andpressed inward against the vaginal fornix in order to provide anobservable or palpable landmark of the incision point for dissecting thecervix and uterus from the vagina and to physically separate theincision area from the nearby ureters. Using such complex uterinemanipulators, the incision for detaching the uterus and cervix from thevagina is executed laparoscopically (e.g., via a hook electrode). Theoccluder, positioned within the vagina when the uterine manipulator isset, makes continuous radial contact with the vaginal wall in order tomaintain pneumoperitoneum after the incision between the vagina and thecervix has been made. The occluder may be a silicone cup pushed up theshaft and pressed into the vagina, or a balloon slid onto the shaft andinflated so that it presses against the vaginal wall.

Current uterine manipulators can present drawbacks in certainsituations. For example, cup or balloon type occluders are in directcontact with the shaft and slid along the shaft for placement within thevagina. In some cases, this can inhibit rotation of the shaft whenattempting to manipulate the position of the uterus, for example to makeincisions around the fornix. In other cases, attempting to rotate theshaft can cause the occluder to slide along the shaft and disengage fromthe vaginal wall, resulting in a loss of pneumoperitoneum. In addition,current uterine manipulators only serve to provide guidance fordetaching the uterus and the cervix from the vagina via laparoscopictools.

Therefore, it would be desirable to have a uterine manipulator thatovercomes these drawbacks.

SUMMARY OF THE INVENTION

The present invention provides a uterine manipulator that is operable todetach the uterus and cervix from the vagina. The uterine manipulatorincludes an umbrella-like tip that creates a secure connection betweenthe uterine manipulator and the uterus and cervix. The uterinemanipulator also includes a pneumooccluder that enables rotation of themanipulator shaft while maintaining pneumoperitoneum. The uterinemanipulator further includes a cutter that travels in a circle at thejunction of the cervix and the vagina, permitting detachment of theuterus and cervix from the top of the vagina.

In accordance with one aspect of the invention, the uterine manipulatorincludes a shaft including a first end and a second end, a handlecoupled to the first end, and a tip assembly coupled to the second endand adapted for insertion into the uterus. The uterine manipulator alsoincludes a cutting assembly coupled around the shaft and adapted toreceive the cervix when the tip assembly is inserted into the uterus.The cutting assembly includes a cup portion and a cutter wire. The cupportion is configured to be positioned at a juncture between the cervixand the vagina and includes with two grooves around its circumference.The cutter wire is configured to be positioned between the two groovesaround the circumference of the cup portion when in a stored position,and then pulled from between the two grooves through tissue at thejuncture to cut the tissue.

In accordance with another aspect of the invention, a method ofperforming a hysterectomy on a patient is provided. Using a uterinemanipulator including a cutting assembly with a cup portion and a cutterwire positioned around a circumference of the cup portion, the methodincludes inserting the uterine manipulator into the vagina until the cupportion reaches a juncture between the patient's vagina and thepatient's cervix, piercing tissue at the juncture with the cutter wire,and grasping the cutter wire with a laparoscopic instrument. The methodalso includes cutting the tissue by pulling the cutter wire out from thecup portion with the laparoscopic instrument until the cutter wire iscompletely removed from the cup portion, and receiving the cutter wirewithin the laparoscopic instrument as the cutter wire is pulled from thecup portion.

The foregoing and other advantages of the invention will appear from thefollowing description. In the description, reference is made to theaccompanying drawings which form a part hereof, and in which there isshown by way of illustration a preferred embodiment of the invention.Such embodiment does not necessarily represent the full scope of theinvention, however, and reference is made therefore to the claims andherein for interpreting the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a uterine manipulator according to thepresent invention.

FIG. 2 is another perspective view of the uterine manipulator of FIG. 1.

FIG. 3 is an exploded perspective view of the uterine manipulator ofFIG.

FIGS. 4A and 4B are partial side views of a handle and a tip assembly,respectively, of the uterine manipulator of FIG. 1.

FIGS. 5A and 5B are additional partial side views of the handle and thetip assembly, respectively, of the uterine manipulator of FIG. 1.

FIGS. 6A-6C are side views of the uterine manipulator of FIG. 1 indifferent pivoting positions.

FIGS. 7A-7D are side and front views of the handle assembly of theuterine manipulator of FIG. 1 in different pivoting positions.

FIGS. 8A and 8B are side views of the uterine manipulator of FIG. 1 in aretracted position and an expanded position, respectively.

FIGS. 9A and 9B are perspective views of a cutting assembly and abackstop, respectively, of the uterine manipulator of FIG. 1.

FIGS. 10A and 10B are side views of the cutting assembly and anelectrical connector assembly, respectively, of the uterine manipulatorof FIG. 1.

FIG. 11 is a perspective view of a pneumooccluder of the uterinemanipulator of FIG. 1.

FIGS. 12A-12D are cross-sectional views of a pelvic cavity and theuterine manipulator of FIG. 1.

FIG. 13 is a perspective view of a manipulator, cup, and cuttingassembly in accordance with the present invention.

FIG. 14 is a series of views showing use of the cutting assembly of FIG.13 in accordance with the present invention.

FIGS. 15A-15B are side views of a uterine manipulator according toanother aspect of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 illustrate a functional uterine manipulator 10, accordingto the invention, for use in vaginal hysterectomies, laparoscopicallyassisted vaginal hysterectomies, and/or other pelvic procedures. Theuterine manipulator 10 can include a handle 12, a shaft 14, a tipassembly 16, a cutting assembly 18, a pneumooccluder 20, and anelectrical connector assembly 22. During use, the uterine manipulator 10can be inserted into a patient's vagina 110, as shown in FIG. 12A, andthen guided past the cervix 112 and into the uterus 114, as shown inFIG. 12B, using the handle 12. More specifically, as shown in FIGS. 12Band 12C, when the uterine manipulator 10 is inserted, the tip assembly16 can be positioned in the uterus 114, the cutting assembly 18 can bepositioned adjacent to the vaginal fornix 118 and can press against thecervix 112, and the pneumooccluder 20 can be positioned inside thevagina 110.

As shown in FIG. 3, the tip assembly 16 can include an expansion tip 24,a tip shaft 26, expansion elements 28, an abutment 30, and a tip housing32, and the handle 12 can include a handle housing 34, an expansionactuator 36, a cap 38, a hinge 40, hinge pins 42, and a pivoting element44. The shaft 14 can be coupled to the tip assembly 16 via the tiphousing 32, and can be coupled to the handle 12 via the pivoting element44. The tip assembly 16 can also be coupled to the handle 12 viaconnectors 46. As shown in FIGS. 4A and 4B, the connectors 46 can berouted from inside the handle housing 34, through the shaft 14, andcoupled to the tip housing 32. In addition, as shown in FIGS. 3, 5A and5B, expansion connectors can be coupled to the expansion actuator 36,routed from inside the handle housing 34 through the shaft 14 andcoupled to the expansion tip 24 for actuating the tip assembly 16, asfurther described below. In some implementations of the presentinvention, some or all of the components of the uterine manipulator 10can be disposable. In addition, in some implementations, some or all ofthe components may be removable from one another, for example, so thatdisposable components can be uncoupled from permanent components andreplaced with new disposable components.

As shown in FIGS. 6A-6C, the tip assembly 16, the shaft 14, and thehandle 12 can be pivotable relative to each other at two separate pivotpoints 50, 52. The first pivot point 50 and the second pivot point 52can facilitate insertion of the uterine manipulator 10 into the uterus114 and can also facilitate repositioning of the uterus 114 during thehysterectomy. The first pivot point 50 can be located at the connectionbetween the tip housing 32 and the shaft 14. For example, as shown inFIGS. 4B and 5B, the end 54 of the tip housing 32 can be positionedbetween end components 56 of the shaft 14 so that through holes 58 ineach component 54, 56 are aligned, and a pin 60 can be routed throughthe through holes 58 to permit a pivotable connection. The second pivotpoint 52 can be located at the connection between the shaft 14 and thehandle 12. For example, as shown in FIGS. 4A, 5A, and 7A-7D, the shaft14 can be fixed to the pivoting element 44 (e.g., via a pin 60 andthrough hole 58 connection) and the pivoting element 44 can be pivotableabout the hinge 40 within the handle housing 34. More specifically, thehinge pins 42 can extend through the handle housing 34, the hinge 40,and a track 62 of the pivoting element 44, as best shown in FIG. 7D. Thetrack 62 can be ribbed so that the pivoting element 44 cannot freelyslide within it. Rather, the pivoting element 44 can be substantiallyfixed at specific points along the ribbed track 62 and only adjusted byapplying an amount of force. This can prevent unwanted movement of thesecond pivot point 52 unless a deliberate force is applied.

In some implementations of the present invention, an additionalmechanism (for example, in the handle 12), can be used to control bothpivot points 50, 52. For example, if the additional mechanism isactuated in a first direction, both pivot points 50, 52 can be locked inplace. If the additional mechanism is actuated in a second direction,both pivot points 50, 52 can be unlocked and maneuverable. In addition,in some implementations of the invention, the shaft 14 can beconstructed of a non-rigid, flexible material to facilitate insertion ofthe uterine manipulator 10 into the uterus 114.

The tip assembly 16 can act as an umbrella-like expansion componentcapable of being adjusted between a retracted position and an expandedposition. As a result, the tip assembly 16 can replace conventionalintra-uterine balloon elements. The tip assembly 16 can be situated intothe retracted position, as shown in FIGS. 8A and 12B, to facilitateinsertion into the uterus 114 (e.g., until the abutment 30 reaches thecervix 112). Once inserted into the uterus 114, the tip assembly 16 canbe deployed into the expanded position, as shown in FIGS. 8B and 12C, tofacilitate a secure connection between the uterine manipulator 10 andthe uterus 114 and cervix 112.

The expansion elements 28 can be spring-like elements capable of beingin compression (e.g., shortened in length) and in tension (e.g.,lengthened). Generally, pulling the expansion actuator 36 away from thehandle housing 34 causes the expansion elements 28 to compress andexpand outward circumferentially, situating the tip assembly 16 into theexpanded position. Pushing the expansion actuator 36 back into thehandle housing 34 causes the expansion elements 28 to retract back intotension and lengthen, situating the tip assembly 16 into the retractedposition. Alternatively, the expansion actuator 36 can be twisted orrotated, rather than pulled and pushed from the handle housing 34, toadjust the expansion elements 28.

More specifically, when assembled, as shown in FIGS. 4B and 5B, theexpansion tip 24 can slide into the tip shaft 26 until an end stop 64 ofthe expansion tip 24 reaches the end 66 of the tip shaft 26. Theexpansion elements 28 can fit over the tip shaft 26 until a first end 68of the expansion elements 28 reaches the end 66 of the tip shaft 26.Both the expansion tip 24 and the tip shaft 26 can be slid into the tiphousing 32, while the second end 70 of the expansion elements 28 canrest against an outer edge 72 of the tip housing 32. Pulling theexpansion actuator 36 outward from the handle housing 34 causes theexpansion connectors 48 to pull the expansion tip 24, and the tip shaft26, further into the tip housing 32. Because the expansion elements 28rest against the edge 72 of the tip housing 32, they are compressed(i.e., shortened in length) when the expansion tip 24 and the tip shaft26 are forced into the tip housing 32. Shortening of the expansionelements 28 causes them to expand in their circumferential direction,therefore situating the tip assembly 16 into the expanded position. Inthe reverse, pressing the expansion actuator 36 back into the housingreleases the pulling tension of the expansion connectors 48 on theexpansion tip 24. The expansion elements 28 can be in a resting statewhen in tension and thus, without the pulling tension by the expansionconnectors 48, the expansion elements 28 will revert back to theirresting, retracted state, thereby pulling the expansion tip 24 and thetip shaft 26 back out from the tip housing 32 and situating the tipassembly 16 into the retracted position.

Referring back to FIGS. 1 and 2, the cutting assembly 18 can be slidover the shaft 14 and can be rotatable about the shaft 14. The cuttingassembly 18 can include a backstop 74, a tube 76, a cutting handle 78,fasteners 80, and a spring 81. The backstop 74 can be positioned at afirst end of the tube 76 and the cutting handle 78 can be positioned ata second, opposite end of the tube 76. The tube 76 can be slid over theshaft 14 and the cutting handle 78 can help maneuver the cuttingassembly 18 along and/or around the shaft 14. The fasteners 80 can helpfix the cutting assembly 18 in place along the shaft 14. The backstop 74can receive the cervix 112 and come in contact with the vaginal fornix118 when the uterine manipulator 10 is in position. The backstop canthen be maneuvered in a circular manner to cut around the cervix 112 fordetaching the cervix 112 and the uterus 114 from the vagina 110, asshown in FIG. 12D. More specifically, as shown in FIGS. 10A and 10B, thebackstop 74 can include a round cup portion 82 and a cutter 84 extendingoutward from the cup portion 82. During use, the cutting assembly 18 canbe pressed up against the abutment 30 of the tip assembly 16 so that thecup portion 82 extends past the abutment 30 and engages the fornix,stretching and forcing the fornix upward and away from the ureters. Thecutter 84 can pierce through the tissue of the fornix, transecting theuterus 114 and the cervix 112 from the top of the vagina 110.

The cutting assembly 18 can be rotated about the shaft 14 (e.g., by thecutting handle 78), allowing the cutter 84 to travel in a circle at thejunction of the cervix 112 and the vagina 110 and permitting completetransection of the uterus 114 and the cervix 112 from the vagina 110.The spring 81 can help distribute rotational forces evenly across thetube 76 when the cutting assembly 18 is rotated, for example, to preventthe tube 76 from breaking due to excess torque concentrated along oneportion of the tube 76.

The electrical connector assembly 22 can advance the cutter 84 outwardfrom the cup portion 82 to achieve the detachment procedure describedabove, and can retract the cutter 84 inward to facilitate insertion ofthe uterine manipulator 10 into the uterus 114 without piercing thevaginal walls 120 prior to proper positioning of the uterine manipulator10. In addition, the electrical connector assembly 22 can provide anelectrical connection between the cutter 84 and an electrosurgical unit(not shown) in order to provide hemostasis during the detachmentprocedure. The electrical connector assembly 22 can include a handle 94,a cap 96, a button 98, tubing 100, 102, and electrical connectors 104,106. On one end of the electrical connector assembly 22 (i.e., adjacentto the cap 96), the tubing 100 and the electrical connectors 104 can berouted to the electrosurgical unit. On the other end of the electricalconnector assembly 22, the tubing 102 and the electrical connectors 106can be routed to the cutter 84. The electrical connectors 104, 106 canbe electrically connected through the button 98 so that current can berouted from the electrosurgical unit to the cutter 84. Also, theelectrical connectors 106 can be coupled to the cutter 84 and the button98 so that pressing the button 98 forward and backward causes the cutter84 to extend and retract, respectively.

Referring to FIG. 11, the pneumooccluder 20 can include a balloon 86, afilling tube 88, and a bearing 90. The bearing 90 can be in contact withthe tube 76 of the cutting assembly 18, and the balloon 86 can bepositioned around the bearing 90. As shown in FIG. 11, the bearing 90can include an outer groove 92 to allow passage of the electricalconnector assembly tubing. During use, the pneumooccluder 20 can bepositioned within the vagina 110 when the uterine manipulator 10 is setwithin the uterus 114. Once in position, the balloon 86 can be inflatedvia the filling tube 88 (e.g., with air, water, saline, or anotherfluid) in order to seal the distal vaginal cavity 122 from the proximalvaginal cavity 124. This can help maintain pneumoperitoneum once theincision has been made between the vagina 110 and the cervix 112 (i.e.,causing the proximal vaginal cavity 124 to be in fluid communicationwith the abdominal cavity). As a result of the bearing 90, the shaft 14and/or the cutting assembly tube 76 can be rotated without requiringrotation of the balloon 86. Because the balloon 86 can be set in placeand does not need to be rotated when the shaft 14 or the cuttingassembly 18 is rotated, the risk of losing pneumoperitoneum is greatlyreduced.

Thus, the uterine manipulator 10 can be inserted into a patient's vagina110 while in the retracted position, as shown in FIG. 12A. The uterinemanipulator 10 can then be further guided through the vagina 110, pastthe cervix 112, and into the uterus 114, while still in the retractedposition, as shown in FIG. 12B. Once set in the uterus 114, the uterinemanipulator 10 can be situated into the expanded position, as shown inFIG. 12C, in order to facilitate a secure connection between the uterinemanipulator 10 and the uterus 114. In addition, once the uterinemanipulator 10 is set within the uterus 114, the pneumooccluder 20 cancontact the vaginal wall 120 in order to seal the uterus 114 from theoutside environment and the backstop 74 can abut the vaginal fornix 118,causing it to stretch upward. Once the uterine manipulator 10 issituated into the expanded position, the cutter 84 can be extended andthe cutting handle 78 can be rotated in order to transect the uterus 114and the cervix 112 from the top of the vagina 110. The uterinemanipulator 10 of the present invention and its above-describedprocedures can thus eliminate the need for a colpotomy incision vialaparoscopic tools, as is required in conventional laparoscopicallyassisted vaginal hysterectomies.

Embodiments of the invention may include any combination of one or moreof the above-described components and/or other conventional uterinemanipulator components. The above-described components, such as thecutting assembly 18, the tip assembly 16, and the pneumooccluder 20 canfunction independent from one another and therefore can be individuallyincorporated into a uterine manipulator with or without the othercomponents. For example, it may be preferable to include thepneumooccluder 20 as described above with a conventional uterinemanipulator to best execute a specific pelvic procedure.

For example, referring to FIG. 13, a cutting assembly 200 isillustrated. The cutting assembly 200 may be used with the functionaluterine manipulator 10 of the preceding figures or may be used withother systems. The cutting assembly 200 includes a cup portion 202 andan expansion tip 204 extending therethrough. As illustrated, theexpansion tip 204 may be a balloon-type design or other configurations,such as described above. Associated with the cup portion 202 is a cutteror cutter wire 206. The cup portion 202 is designed to engage the cervix112, such as previously described. The cutter 206 is formed as a narrowwire, with a looped tip, embedded between two grooves 208, 210 on thecup portion 202 (that is, around the circumference of the cup portion202).

FIGS. 15A-15B illustrate another uterine manipulator 300. The uterinemanipulator 300 can include a handle 312, a shaft 314, a tip assembly316, and a cutting assembly 318. Unless otherwise stated, the elementsof the uterine manipulator 300 can be similar in function and structureto those of the above-described uterine manipulator 100 of the previousfigures. Also, the uterine manipulator 300 can incorporate any of theabove-described elements of the previous figures. For example, the tipassembly 316 can include an expansion tip 324, a tip shaft 326,umbrella-like expansion elements 328, an abutment 330, and a tip housing332. The handle 312 can include a handle housing 334 and an expansionactuator 336. Twisting or rotating the expansion actuator 336 in a firstdirection causes the expansion elements 328 to compress and expandoutward circumferentially, situating the tip assembly 316 into theexpanded position. Twisting or rotating the expansion actuator 336 in asecond, opposite direction causes the expansion elements 328 to retractback into tension and lengthen, situating the tip assembly 316 into theretracted position.

The cutting assembly 318 can be rotatable about the shaft 314. Morespecifically, as shown in FIGS. 15A-15B, the uterine manipulator 300 caninclude a flexible shaft portion 315 along which the cutting assembly318 can be slid laterally and/or rotated for proper positioning oroperation. The cutting assembly 318 can include a cup portion 382 and acutter or cutter wire 384. Similar to the cutter 206 of FIG. 13, thecutter 384 can be formed as a narrow wire, with a looped tip 383,embedded between grooves (not shown) on the cup portion 382. Inaddition, the cup portion 382 can include a projection 385 to assist anoperator in locating the cutter 384 during an operation, to help shieldthe cutter 384 during insertion of the uterine manipulator 300, and/orto help push the cutter 384 through the vaginal tissue.

Referring to FIG. 14, the cutter 206 (or the cutter 384) is preset in astored position 212 between the grooves 208, 210 (for example, when theuterine manipulator 100/300 is being inserted into a patient's uterus114). The cutter wire may be secured between the grooves 208, 210 bysmall, thin bridges (not shown) around the edge of the cup portion 202,with the looped tip of the cutter 206 extending outward from the grooves208, 210 at a 12 o'clock position. The bridges may be thin enough thatthey can be easily broken by pulling the cutter 206 against the bridgeswith sufficient force. The cutter 206 is designed to move from thestored position 212 to an extended position 214 where the cutter 206 maybe pushed through the top of the vagina (for example, with the help ofthe projection 383 of cup portion 382) after the cup portion 202 hasbeen positioned at a juncture between the cervix 112 and the vagina 110(for example, the vaginal fornix 118). In a further extended position216, the cutter 206 can be pulled in by a laparoscopic instrument 218,or “wand,” that is introduced laparoscopically.

The instrument 218 includes a trocar 220 that extends through the skin222 to present a handle 224 to a clinician. The instrument 218 alsoincludes a small grasper 217 at its proximal end that can grasp orengage with the looped tip of the cutter 206. Using the handle 224, theinstrument 218 is directed around the cup portion 202 and, as a result,pulls the cutter 206 at position 226. As the cutter 206 makes contactwith tissue at the juncture of the vagina 110 and cervix 112, the tissueis cut, thus separating the vagina 110 from the cervix 112 and uterus114. At a final position 228, for example, once the cutter 206 has beenpulled around the circumference of the cup portion 202, the cutter 206can be separated from the cup portion 202. The laparoscopic instrument,with the entire cutter 206, can then be removed through a laparoscopicport at the skin 222.

The inner groove 210 of the cup portion 202 may be taller than the outergroove 208 to prevent the cutter 206 from being pulled inward (insteadof upward or outward) as the instrument 218 pulls the cutter 206. Inaddition, the laparoscopic instrument 218 can include an outerinsulation cover 219 that is pushed forward while the cutter 206 ispulled out of the grooves 208, 210. That is, the cutter 206 is pulledinto or received in the laparoscopic instrument 218 so that the cutter206 is covered by the laparoscopic instrument 218 during operation,thereby enhancing safety given that the cutting wire or blade (which maybe carrying electrical current, as described below) is not exposed atany given time.

The cutter 206 can either cut the vagina “cold” (without electricalcurrent) or with an electrical current, based on surgeon preference. Forexample, a distal end of the laparoscopic instrument 218 can connect toan electrosurgical unit (not shown) or electrical connector assembly,which may conduct monopolar or bipolar current. Accordingly, once thelaparoscopic instrument 218 grasps the cutter 206, current is passedthrough the instrument 218 and to the cutter wire 206. Differentoperations can be conducted based on monopolar or bipolarconfigurations. For example, in a monopolar configuration, the cutter206 can be pulled out of the cup portion 202 along its entirecircumference and removed via the laparoscopic instrument 218 (asdescribed above with reference to FIG. 14) while the cup portion 202remains fixed to a shaft (such as shaft 14 or 314). More specifically,the cup portion 202 is not rotated about the shaft during thisoperation. Power during monopolar operation may be relatively high, suchas about 100 watts.

In another example, in a bipolar configuration, the cutter 206 may be ashorter wire, such as about 2 centimeters (cm) to about 3 cm. The cutter206 can be pulled through the vaginal tissue by the laparoscopicinstrument 218, remaining at the 12 o'clock position, and then the cupportion 202 can be rotated about the shaft as the cutter 206 is held inplace. One pole of the bipolar current can be through the laparoscopicinstrument 218 (connected to the cutter wire 206) and the other pole canbe through the cup portion 202.

In yet another example, the shorter cutter 206 can be held between thegrooves 208, 210 by a small ball (not shown) at a distal end of thecutter 206. The ball can help the cutter 206 slide around thecircumference of the cup portion 202 but also prevents the entire cutter206 from being pulled out from between the grooves 208, 210 as thelaparoscopic instrument 218 pulls the cutter 206. Once the cutter 206has traversed the entire circumference of the cup portion 202, a breakor opening (not shown) between the grooves 208, 210 can allow the ballto be pulled out from the cup portion 202 and into the laparoscopicinstrument 218 for removal. This ball configuration can be used withbipolar or monopolar applications. In bipolar applications, a smallmetal lining inside of the grooves 208, 210 can electrically connect thecup portion 202 to the ball (which is electrically connected to thelaparoscopic instrument 218).

In addition, the uterine manipulator 10, 300 of the present invention,or at least one or more components of the uterine manipulator 10, 300can be used with orifice-assisted small incision surgeries (OASIS). Insuch surgeries, instrumentation may be inserted through a patient'sbelly button as well as the patient's vagina 110. This method decouplesthe optical axis (e.g., of a laparoscope inserted through the bellybutton) from the operative axis (e.g., of a surgical tool insertedthrough the vagina 110). In some implementations, the uterinemanipulator 10, 300 can include an extension tool to assist with OASISprocedures.

The present invention has been described in terms of one or morepreferred embodiments, and it should be appreciated that manyequivalents, alternatives, variations, and modifications, aside fromthose expressly stated, are possible and within the scope of theinvention.

The invention claimed is:
 1. A uterine manipulator adapted for insertioninto a uterus for stabilizing and repositioning the uterus during ahysterectomy, where the uterus and cervix are detached from the vagina,the uterine manipulator comprising: a shaft including a first end and asecond end; a handle coupled to the first end; a tip assembly coupled tothe second end and adapted for insertion into the uterus; a cuttingassembly coupled around the shaft and adapted to receive the cervix whenthe tip assembly is inserted into the uterus, the cutting assemblyincluding: a cup portion including two grooves around a circumference ofthe cup portion, the cup portion configured to be positioned at ajuncture between the cervix and the vagina, and a cutter wire configuredto be positioned between the two grooves around the circumference of thecup portion when in a stored position, then pulled from between the twogrooves through tissue at the juncture to cut the tissue, wherein theCuP portion includes a projection that initially pushes the cutter wirethrough the tissue when the cup portion is positioned at the juncturebetween the cervix and the vagina.
 2. The uterine manipulator of claim1, wherein the cutter wire includes a looped tip configured to engage alaparoscopic instrument.
 3. The uterine manipulator of claim 2, whereinthe looped tip is configured to extend outward from between the twogrooves when in the stored position.
 4. The uterine manipulator of claim1, wherein the cup portion is rotatable about the shaft.
 5. The uterinemanipulator of claim 1, wherein the cup portion includes bridges acrossthe grooves to secure the cutter wire in the stored position.
 6. Theuterine manipulator of claim 1 further comprising an electricalconnector assembly operable to provide electrical current to the cupportion.
 7. The uterine manipulator of claim 6, wherein the electricalconnector assembly is configured to provide one or monopolar current andbipolar current.
 8. The uterine manipulator of claim 1, wherein the twogrooves include an inner groove and an outer groove, wherein the innergroove extends further upward than the outer groove to force the cutterwire upward rather than inward when the cutter wire is pulled frombetween the two grooves.
 9. The uterine manipulator of claim 1, whereina length of the cutter wire is about 2 centimeters to about 3centimeters.
 10. The uterine manipulator of claim 1, wherein the cutterwire includes a ball along a first end, wherein the ball is configuredto slide between the two grooves.
 11. The uterine manipulator of claim10, wherein the cup portion includes metal lining between the twogrooves to enable electrical connection between the cup portion and theball.
 12. The uterine manipulator of claim 10, wherein the cup portionincludes a break between the two grooves, the break being large enoughto permit the ball to be removed from between the two grooves.
 13. Theuterine manipulator of claim 1 and further comprising a laparoscopicinstrument configured to engage the cutter wire.
 14. The uterinemanipulator of claim 13 and further comprising an electrical connectorassembly operable to provide electrical current to cutter wire throughthe laparoscopic instrument.
 15. The uterine manipulator of claim 13,wherein the laparoscopic instrument includes a grasper configured tograsp the cutter wire.
 16. The uterine manipulator of claim 13, whereinthe laparoscopic instrument includes an outer insulation coverconfigured to receive the cutter wire as it is pulled through thetissue.
 17. The uterine manipulator of claim 13, wherein thelaparoscopic instrument is configured to pull the cutter wire from thecup portion as the cup portion remains fixed on the shaft.
 18. Theuterine manipulator of claim 13, wherein the laparoscopic instrument isconfigured to hold the cutter wire as the cup portion is rotated aroundthe shaft.
 19. A method of performing a hysterectomy on a patient with auterine manipulator including a cutting assembly with a cup portion anda cutter wire positioned around a circumference of the cup portion, themethod comprising the steps of: inserting the uterine manipulator intothe vagina until the cup portion reaches a juncture between thepatient's vagina and the patient's cervix; piercing tissue at thejuncture with the cutter wire; grasping the cutter wire with alaparoscopic instrument; cutting the tissue by pulling the cutter wireout from the cup portion with the laparoscopic instrument until thecutter wire is completely removed from the cup portion; and receivingthe cutter wire within the laparoscopic instrument as the cutter wire ispulled from the cup portion.